US8986728B2ActiveUtilityPatentIndex 52
Soluble implantable device comprising polyelectrolyte with hydrophobic counterions

Assignee: HOSSAINY SYED F APriority: May 30, 2008Filed: Jul 9, 2012Granted: Mar 24, 2015
Est. expiryMay 30, 2028(~1.9 yrs left)· nominal 20-yr term from priority
Inventors:HOSSAINY SYED F A TROLLSAS MIKAEL O KLEINER LOTHAR W
A61L 31/148A61L 27/34A61L 31/048A61L 31/06A61L 31/16C09D 189/00C09D 101/286A61L 29/085C08L 1/286A61F 2/82A61L 29/148A61L 2300/602C08L 5/08C08L 89/00C09D 105/08A61L 27/58A61L 31/10
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Claims
Abstract

The present invention provides an implantable device having a biosoluble coating or a biosoluble body structure comprising a polyelectrolyte and a counterion and the methods of making and using the same.
Claims

exact text as granted — not AI-modified
The invention claimed is: 
     
       1. An implantable device, comprising a biosoluble body structure and optionally comprising a coating deposited upon the body structure of the implantable device, the biosoluble body structure or comprising:
 a complex comprising a polyelectrolyte and a counterion, the counterion being p-propylbenzenesulfonate. 
 
     
     
       2. The implantable device of  claim 1 , wherein the biosoluble body structure further comprises a bioactive agent. 
     
     
       3. The implantable device of  claim 1 , wherein the optional coating is present. 
     
     
       4. The implantable device of  claim 1 , wherein the complex has a high dissociation constant (pKa). 
     
     
       5. The implantable device of  claim 1 , wherein the biosoluble body structure further comprises a biosoluble polymer selected from poly(ethylene glycol) (PEG), poly(lactide-co-glycolide)-co-poly(ethylene glycol) (PLGA-PEG) block copolymers, other PEG copolymers, poly(vinyl alcohol) (PVA), hyaluronic acid, hydroxyl cellulose, carboxymethylcellulose (CMC), polysaccharides, phosphoryl choline containing polymers, chitosan, collagen, and combinations thereof. 
     
     
       6. The implantable device of  claim 2 , wherein the bioactive agent is selected from paclitaxel, docetaxel, estradiol, 17-beta-estradiol, nitric oxide donors, super oxide dismutases, 4-amino-2,2,6,6-tetramethylpiperidine-1-oxyl (4-amino-TEMPO), biolimus, tacrolimus, dexamethasone, rapamycin, 40-O-(2-hydroxy)ethyl-rapamycin (everolimus), 40-O-(3-hydroxy)propyl-rapamycin, 40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin, 40-O-tetrazole-rapamycin, 40-epi-(N1-tetrazolyl)-rapamycin (ABT-578), γ-hiridun, clobetasol, pimecrolimus, imatinib mesylate, midostaurin, fenofibrate, and combinations thereof. 
     
     
       7. The implantable device of  claim 1 , wherein the body structure of the implantable device is a stent. 
     
     
       8. An implantable device, comprising a biosoluble body structure formed of a material that is sparingly soluble in an aqueous medium,
 the biosoluble body structure comprising: 
 a complex comprising a polyelectrolyte and a counterion, the counterion being p-propylbenzenesulfonate. 
 
     
     
       9. A method of fabricating an implantable device, comprising
 forming a biosoluble body structure comprising: 
 a complex comprising a polyelectrolyte and a counterion, the counterion being p-propylbenzenesulfonate. 
 
     
     
       10. The method of  claim 9 , wherein the body structure further comprises a bioactive agent. 
     
     
       11. The method of  claim 9 , wherein the biosoluble body structure further comprises a biosoluble polymer selected from poly(ethylene glycol) (PEG), poly(lactide-co-glycolide)-co-poly(ethylene glycol) (PLGA-PEG) block copolymers, other PEG copolymers, poly(vinyl alcohol) (PVA), hyaluronic acid, hydroxyl cellulose, carboxymethylcellulose (CMC), polysaccharides, phosphoryl choline containing polymers, chitosan, collagen, and combinations thereof. 
     
     
       12. The method of  claim 10 , wherein the bioactive agent is selected from paclitaxel, docetaxel, estradiol, 17-beta-estradiol, nitric oxide donors, super oxide dismutases, 4-amino-2,2,6,6-tetramethylpiperidine-1-oxyl (4-amino-TEMPO), biolimus, tacrolimus, dexamethasone, rapamycin, 40-O-(2-hydroxy)ethyl-rapamycin (everolimus), 40-O-(3-hydroxy)propyl-rapamycin, 40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin, 40-O-tetrazole-rapamycin, 40-epi-(N1-tetrazolyl)-rapamycin (ABT-578), γ-hiridun, clobetasol, pimecrolimus, imatinib mesylate, midostaurin, fenofibrate, and combinations thereof. 
     
     
       13. A method of treating a medical condition in a blood vessel of a patient comprising implanting in the blood vessel of the patient an implantable device according to  claim 1 . 
     
     
       14. A method of treating a medical condition in a blood vessel of a patient comprising implanting in the blood vessel of the patient an implantable device according to  claim 6 . 
     
     
       15. The implantable device of  claim 3 , wherein the optional coating comprises a bioactive agent, which may be the same as or different from, any bioactive agent of the biosoluble body structure, if present. 
     
     
       16. The implantable device of  claim 15 , wherein the bioactive agent of the coating is selected from paclitaxel, docetaxel, estradiol, 17-beta-estradiol, nitric oxide donors, super oxide dismutases, 4-amino-2,2,6,6-tetramethylpiperidine-1-oxyl (4-amino-TEMPO), biolimus, tacrolimus, dexamethasone, rapamycin, 40-O-(2-hydroxy)ethyl-rapamycin (everolimus), 40-O-(3-hydroxy)propyl-rapamycin, 40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin, 40-O-tetrazole-rapamycin, 40-epi-(N1-tetrazolyl)-rapamycin (ABT-578), γ-hiridun, clobetasol, pimecrolimus, imatinib mesylate, midostaurin, fenofibrate, and combinations thereof. 
     
     
       17. The implantable device of  claim 5 , wherein the biosoluble polymer is selected from poly(ethylene glycol) (PEG), poly(lactide-co-glycolide)-co-poly(ethylene glycol) (PLGA-PEG) block copolymers, poly(vinyl alcohol) (PVA), hyaluronic acid, hydroxyl cellulose, carboxymethylcellulose (CMC), chitosan, collagen, and combinations thereof. 
     
     
       18. The method of  claim 11 , wherein the biosoluble polymer is selected from poly(ethylene glycol) (PEG), poly(lactide-co-glycolide)-co-poly(ethylene glycol) (PLGA-PEG) block copolymers, poly(vinyl alcohol) (PVA), hyaluronic acid, hydroxyl cellulose, carboxymethylcellulose (CMC), chitosan, collagen, and combinations thereof. 
     
     
       19. The implantable device of  claim 6 , wherein the bioactive agent is selected from biolimus, tacrolimus, rapamycin, 40-O-(2-hydroxy)ethyl-rapamycin (everolimus), 40-O-(3-hydroxy)propyl-rapamycin, 40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin, 40-O-tetrazole-rapamycin, 40-epi-(N1-tetrazolyl)-rapamycin (ABT-578), and combinations thereof. 
     
     
       20. The method of  claim 12 , wherein the bioactive agent is selected from biolimus, tacrolimus, rapamycin, 40-O-(2-hydroxy)ethyl-rapamycin (everolimus), 40-O-(3-hydroxy)propyl-rapamycin, 40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin, 40-O-tetrazole-rapamycin, 40-epi-(N1-tetrazolyl)-rapamycin (ABT-578), and combinations thereof. 
     
     
       21. A method of fabricating an implantable device, comprising
 forming a biosoluble body structure comprising: 
 a complex comprising a polyelectrolyte and a counterion, the counterion being selected from the group consisting of p-propylbenzenesulfonate, nonyl acid, and combinations thereof; 
 wherein the body structure further comprises a bioactive agent, the bioactive agent being selected from paclitaxel, docetaxel, estradiol, 17-beta-estradiol, nitric oxide donors, super oxide dismutases, 4-amino-2,2,6,6-tetramethylpiperidine-1-oxyl (4-amino-TEMPO), biolimus, tacrolimus, dexamethasone, rapamycin, 40-O-(2-hydroxy)ethyl-rapamycin (everolimus), 40-0-(3-hydroxy)propyl-rapamycin, 40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin, 40-O-tetrazole-rapamycin, 40-epi-(N1-tetrazolyl)-rapamycin (ABT-578), 7-hiridun, clobetasol, pimecrolimus, imatinib mesylate, midostaurin, fenofibrate, and combinations thereof. 
 
     
     
       22. The method of  claim 21 , wherein the biosoluble body structure further comprises a biosoluble polymer selected from poly(ethylene glycol) (PEG), poly(lactide-co-glycolide)-co-poly(ethylene glycol) (PLGA-PEG) block copolymers, other PEG copolymers, poly(vinyl alcohol) (PVA), hyaluronic acid, hydroxyl cellulose, carboxymethylcellulose (CMC), polysaccharides, phosphoryl choline containing polymers, chitosan, collagen, and combinations thereof. 
     
     
       23. The method of  claim 22 , wherein the biosoluble polymer is selected from poly(ethylene glycol) (PEG), poly(lactide-co-glycolide)-co-poly(ethylene glycol) (PLGA-PEG) block copolymers, poly(vinyl alcohol) (PVA), hyaluronic acid, hydroxyl cellulose, carboxymethylcellulose (CMC), chitosan, collagen, and combinations thereof. 
     
     
       24. The method of  claim 21 , wherein the bioactive agent is selected from biolimus, tacrolimus, rapamycin, 40-O-(2-hydroxy)ethyl-rapamycin (everolimus), 40-O-(3-hydroxy)propyl-rapamycin, 40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin, 40-O-tetrazole-rapamycin, 40-epi-(N1-tetrazolyl)-rapamycin (ABT-578), and combinations thereof.
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